US20070233241A1 - Tissue Graft Fixation - Google Patents
Tissue Graft Fixation Download PDFInfo
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- US20070233241A1 US20070233241A1 US11/688,447 US68844707A US2007233241A1 US 20070233241 A1 US20070233241 A1 US 20070233241A1 US 68844707 A US68844707 A US 68844707A US 2007233241 A1 US2007233241 A1 US 2007233241A1
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- Prior art keywords
- graft
- graft fixation
- fixation device
- bone
- hole
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/08—Muscles; Tendons; Ligaments
- A61F2/0811—Fixation devices for tendons or ligaments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0404—Buttons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0414—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/08—Muscles; Tendons; Ligaments
- A61F2/0811—Fixation devices for tendons or ligaments
- A61F2002/0847—Mode of fixation of anchor to tendon or ligament
- A61F2002/0852—Fixation of a loop or U-turn, e.g. eyelets, anchor having multiple holes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/08—Muscles; Tendons; Ligaments
- A61F2/0811—Fixation devices for tendons or ligaments
- A61F2002/0876—Position of anchor in respect to the bone
- A61F2002/0882—Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone
Definitions
- This present disclosure relates to tissue graft fixation.
- a ligament such as an anterior cruciate ligament (ACL), that has ruptured and is non-repairable, is generally replaced arthroscopically by a tissue graft.
- the tissue graft can be harvested from a portion of a patellar tendon having so called “bone blocks” at each end, and from the semitendonosis and gracilis.
- the tissue graft can be formed from synthetic materials or from a combination of synthetic and natural materials.
- the replacement tissue graft is implanted by securing one end of the tissue graft in a socket formed in a passage within the femur, and passing the other end of the graft through a passage formed in the tibia.
- sutures are used to affix each end of the tissue graft to a fastener (e.g., an interference screw or a post), which is then secured to the bone.
- a graft fixation member e.g., a fixation button
- the graft fixation member is coupled to the tissue graft and a suture, or other pulling means, is used to pull the fixation member/tissue graft combination through the bone tunnel.
- these fixation members can be cumbersome to use, due to the hole and suture loop placements on the member making it difficult to pass the graft through the tunnel.
- the member comes in various sizes, which makes it difficult to center the member on the top opening of the femoral tunnel.
- the member frequently rotates off-axis, rather than maintaining a generally longitudinal orientation.
- a graft fixation device includes a body configured and arranged for passage through a bone tunnel when oriented generally longitudinally with respect to the bone tunnel, and for residing against bone defining an opening to the bone tunnel when oriented generally transversely with respect to the bone tunnel.
- the body defines an enclosed channel configured for receiving a tissue graft such that the tissue graft is substantially evenly distributed about a longitudinal extent of the body so that the body maintains a generally longitudinal orientation during passage through the tunnel, and includes a cross bar about which the tissue graft is looped when the body resides against the bone defining the opening to the bone tunnel.
- the body includes a leading end portion defining a hole, and a trailing end portion defining a hole.
- the trailing end portion has an open end or a closed end.
- the trailing end portion has a closed end wherein the closed end is angled relative to the body at an angle ⁇ , which is about 45 degrees.
- the body includes a trailing end portion having an open end and a leading end portion having an open end.
- a graft fixation device in another aspect, includes an intermediate portion having at least two tabs, the tabs extending transverse to the intermediate portion, the intermediate portion including at least one hole, the hole being located between the tabs.
- the device further includes a first end portion including at least one hole and a second end portion including at least one hole.
- intermediate portion includes at least two holes.
- the graft fixation device further includes a continuous loop of material passing through the hole of the intermediate portion. The material may include a suture.
- a graft fixation device in yet another aspect, includes an intermediate portion including a hinge coupled to the intermediate portion, the hinge and the intermediate portion defining a channel configured for receiving a tissue graft.
- the device further includes a first end portion having at least one hole and a second end portion having at least one hole.
- the hinge is U-shaped.
- the hinge is rotatable relative to the fixation device.
- a method in another general aspect, includes looping a graft through an opening in a graft fixation device, and pulling the graft fixation device and looped graft through a bone tunnel.
- the graft fixation device is maintained substantially longitudinally oriented relative to the tunnel while being pulled through the bone tunnel.
- Embodiments of this aspect may include drilling at least one bone tunnel extending in a generally lateral direction through a knee joint.
- the method further includes looping grafts through openings in multiple graft fixation devices, drilling multiple bone tunnels extending in a generally lateral direction through a knee joint, and pulling each of the graft fixation devices and looped grafts through the bone tunnels.
- the graft fixation devices are each configured such that the graft fixation devices are maintained substantially longitudinally oriented relative to the tunnels while being pulled through the tunnels.
- a method includes providing a graft fixation device having an intermediate portion including at least two tabs, the tabs extending transverse to the intermediate portion, the intermediate portion including at least one hole, the hole being located between the tabs and including a continuous loop of material, drilling a bone tunnel extending in a generally lateral direction through a knee joint, looping a tissue graft through the continuous loop of material such that the tissue graft is situated between the tabs, and pulling the graft fixation device and looped graft through the bone tunnel, the graft fixation device being configured such that the graft fixation device is maintained substantially longitudinally oriented relative to the tunnel while being pulled through the bone tunnel.
- the material may include a suture.
- the method further includes placing the fixation member over an opening to the bone tunnel such that the tabs extend into the bone tunnel.
- the graft fixation device further includes a first end portion including at least one hole and a second end portion including at least one hole.
- method further includes providing multiple graft fixation devices, each graft fixation device having an intermediate portion including at least two tabs, the tabs extending transverse to the intermediate portion, the intermediate portion including at least one hole, the hole being located between the tabs and including a continuous loop of material, drilling multiple bone tunnels extending in a generally lateral direction through a knee joint, looping a tissue graft through each of the continuous loop of material such that the tissue graft is situated between the tabs of each of the graft fixation devices, and pulling the graft fixation devices and looped grafts through the bone tunnels, the graft fixation devices being configured such that the graft fixation devices are maintained substantially longitudinally oriented relative to the tunnels while being pulled through the tunnels.
- Each of the graft fixation devices may further include a first end portion having at least one hole and a second end portion having at least one hole.
- a method includes providing a graft fixation device having an intermediate portion having a rotatable hinge coupled to the intermediate portion, the hinge and the intermediate portion defining a channel configured for receiving a tissue graft; drilling a bone tunnel extending in a generally lateral direction through a knee joint; looping a tissue graft through the channel; and pulling the graft fixation device and looped graft through the bone tunnel, the graft fixation device being configured such that the graft fixation device is maintained substantially longitudinally oriented relative to the tunnel while being pulled through the bone tunnel.
- the method further includes rotating the hinge relative to the fixation member and placing the fixation member over an opening to the bone tunnel such that the hinge extends into the bone tunnel.
- the graft fixation device further includes a first end portion including at least one hole and a second end portion including at least one hole.
- the method further includes providing multiple graft fixation devices, each graft fixation device including an intermediate portion having a rotatable hinge coupled to the intermediate portion, the hinge and the intermediate portion defining a channel for receiving a tissue graft; drilling multiple bone tunnels extending in a generally lateral direction through a knee joint; looping a tissue graft through each of the channels of the multiple graft fixation devices; and pulling each of the graft fixation devices and looped grafts through the multiple bone tunnels, the graft fixation devices being configured such that each graft fixation device is maintained substantially longitudinally oriented relative to the tunnels while being pulled through the tunnels.
- Each of the graft fixation devices may further include a first end portion including at least one hole and a second portion including at least one hole.
- a graft fixation device in another aspect, includes an intermediate portion having a prominence on a surface of the intermediate portion. The prominence facilitates alignment of a tissue graft with the device as the device is being pulled through a bone tunnel.
- the fixation member is advantageously centered within the bone tunnel during passage through the bone tunnel, thus limiting any tendency of the fixation member to snag on the bone tunnel wall.
- the cross-bar, tabs, and hinge all facilitate centering of the graft or suture relative to the opening to the bone tunnel, thus limiting any tendency of the tissue graft or suture to kink against the bone cortex.
- FIG. 1 shows a tissue graft secured within tibia and femoral bone tunnels during an ACL reconstruction procedure.
- FIG. 2B is a perspective view of the fixation member of FIG. 2A .
- FIG. 3A is a side view of an alternative embodiment of a fixation member shown drawing the tissue graft through the femoral bone tunnel.
- FIG. 3B is a perspective view of the fixation member of FIG. 3A .
- FIG. 4A is a side view of an alternative embodiment of a fixation member shown drawing the tissue graft through the femoral bone tunnel.
- FIG. 5B is a perspective view of the fixation member of FIG. 5A .
- FIG. 5C is a bottom view of the fixation member of FIG. 5A .
- FIG. 5D is an end view of the fixation member of FIG. 5A
- FIG. 6B is a side view of an alternative embodiment of a fixation member shown drawing the fixation graft through the femoral tunnel.
- a multiple-bundle technique e.g., more than one femoral channel 14 , tibial channel 16 , tissue graft 200 and fixation member 300 .
- the multiple-bundle technique results in multiple anchor points to transfer stresses evenly across the knee joint and/or permits a surgeon to drill femoral and tibial channels that are more laterally oriented, closer to the joint between the tibia 13 and fibia 15 , and shallower than bone channels that are typically drilled farther away from the knee joint, and thus deeper.
- securing the tissue grafts 200 a , 200 b directly to the fixation members 300 a , 300 b permits the surgeon to drill shallower bone channels than what may be possible when intermediate suture is used to connect a tissue graft to a fixation member, and due to the larger size of the fixation member as compared to conventional fixation members, such as the Endobutton CL, product no. 7209352, available from Smith & Nephew, Inc., permits the bone tunnels to have a uniform cross-section that receives both the tissue graft and the fixation member to lie over the larger sized bone tunnel when the fixation member is positioned against the cortex at the opening to the femoral tunnel.
- the tissue graft 200 is looped through an opening 350 in the fixation member 300 and is pulled through a tibia channel 16 and the femoral channel 14 using a suture 210 passed through a hole 340 defined in a leading end 300 a of the graft fixation member 300 .
- the arms 320 a , 320 b each define one of opposing holes 321 a , 321 b for receiving one or more strands of suture 212 , which is used to flip the fixation member 300 after passage through the femoral tunnel 14 such that the fixation member 300 is positioned against the femur and centered about the femoral opening, as described further below.
- the leading end portion 330 includes a pair of rectangular arms 330 a , 330 b joined by a curved portion 345 which collectively define an oval-shaped, closed-end, tissue graft opening 350 .
- the tissue graft 200 is looped through graft opening 350 with the closed-end of the leading end portion ensuring that the graft 200 remains connected to the fixation member 300 .
- the curved portion 345 defines the suture hole 340 .
- the leading end portion 330 may also be open, similar to the trailing end portion 320 .
- the fixation member would be in the shape of an “H” and each end would include a pair of rectangular arms having opposing holes for receiving one or more strands of suture.
- the cross bar 310 acts as a fulerum for the tissue graft 200 within the bone channels after passage of the fixation member through the channels and positioning of the fixation member against the femoral cortex, as well as allowing tension to be placed on the tissue graft 200 during subsequent fixation of the tissue graft to the surface of the tibia.
- An exemplary fixation member 300 has an overall length of between about 15 mm to about 25 mm, a width of between about 4 mm to about 9 mm, a height of between about 1 mm to about 3 mm, a width of the central bar 310 of between about 1 mm to about 2.5 mm, a length of the leading end channel 350 of between about 5 mm to about 12 mm, a width of the leading end channel 350 of between about 3 mm to about 6 mm, and a thickness of the rectangular arm portions 330 b of between about 1 mm to about 2 mm.
- an alternative fixation member 400 includes a cross bar 410 and a leading end 400 a defining an opening 440 for passage of a lead suture 250 .
- fixation member 400 includes a pair of closed-end channels 450 , 455 .
- the tissue graft 240 is coupled to the fixation member 400 by passing a first section 240 a of the tissue graft 240 through the first closed-end channel 450 of the fixation member 400 to form a graft loop 240 c which includes the first tissue graft section 240 a and a second tissue graft section 240 b .
- the first section 240 a of the tissue graft is then passed around the cross bar 410 and back through the second channel 455 .
- the lead suture 250 may be looped through the channel 450 , rather than being passed through the opening 440 .
- the fixation member 400 includes a first pair of opposing trailing arms 420 a , 420 b and a second pair of opposing leading arms 430 a , 430 b .
- the first pair of arms 420 a , 420 b extend longitudinally from the cross bar 410 and are connected by a curved portion 446 .
- the curved portion 446 , cross bar 410 and arms 420 a , 420 b define the second, closed-end channel 455 .
- the second arms 430 a , 430 b extend longitudinally from the cross bar 410 in a direction opposite from the first arms 420 a , 420 b and are connected by a curved portion 445 .
- the second arms 430 a , 430 b , the cross bar 410 and the curved portion 445 define the first, closed-end channel 450 at the leading end 400 a of the fixation member 400 .
- the closed-end channels 450 , 455 are each oval-shaped channels that are sized to accommodate the tissue graft ends 240 a , 240 b .
- the suture for flipping the fixation member can be looped through channel 455 .
- an alternative fixation member 600 is indirectly coupled to a tissue graft loop 290 by a continuous loop 281 of material passed through central suture holes 682 , 683 within an intermediate portion 610 of the fixation member 600 .
- a lead suture 280 is passed through a lead suture hole 680 at a first end portion 605 of the member 600
- a trailing suture 282 at a second end portion 620 is passed through a trailing suture hole 681 .
- the intermediate portion 610 includes a prominence 630 on a surface 640 of the intermediate portion 610 .
- the prominence 630 is in the form of a pair of transversely extending tabs 615 , 616 .
- the tabs 615 , 616 facilitate alignment of the graft 290 with the fixation member 600 thus limiting any tendency of the fixation member 600 to rotate off-axis as it is being drawn through the bone tunnel.
- tabs 615 , 616 extend into the femoral tunnel when the fixation member 600 is positioned against the cortex at the opening to the tunnel, thereby centering the member 600 on the bone.
- the material 281 may include suture material.
- an alternative fixation member 700 includes a U-shaped, rotatable hinge 716 coupled to and extending from an intermediate portion 710 of the fixation member 700 .
- the U-shaped hinge 716 is a rigid, e.g., such as metallic, member which provides a movable mounting surface for directly connecting a tissue graft 294 thereto.
- the intermediate portion 710 and hinge 716 define a channel 730 therebetween through which the tissue graft is looped.
- a lead suture 292 is passed through a lead suture hole 725 at a leading, or first end 700 a of the fixation member 700 , and another suture 293 is passed through a trailing suture hole 720 at a trailing, or second end 700 b , for flipping the fixation member 700 to position the fixation member 700 transversely to the bone channel opening.
- the U-shaped hinge 716 includes a pair of arms 715 a , 715 b and transversely extending hinge pins 711 , 712 can be, for example, press-fit within the recesses 718 and/or pivotable about a common pin.
- suture attached to the tissue graft can be coupled to the fixation member.
- the suture can be coupled to the fixation member in the same manner as the coupling of the tissue graft directly to the fixation member, as described above.
- the channels can be a variety of shapes, including circular, oval, elliptical and/or rectangular.
- the arms can also have a variety of shapes.
- the leading and/or trailing ends can each be provided with one or more suture holes to facilitate positioning of the fixation member within the bone tunnel, and drawing the fixation member through the bone tunnel, and flipping the fixation member.
- a strand of suture can be extended between the opposing holes ( FIG. 2 b , 321 a , 321 b ) to serve as a stop to enclose the otherwise open end of the channel 355 to secure the trailing end of the tissue graft bundle to the trailing end of the fixation member.
- the graft fixation member is formed from a biocompatible material such as titanium or PEEK, or a bioabsorbable material.
- the tissue graft may include autograft tissue, allograft tissue, or synthetic tissue.
- the fixation member may be positioned inside the bone, thereby lying against the endosteal surface of the near cortex.
- suture material is used.
- other material known to one of ordinary skill in the art that is strong enough to withstand pulling the fixation member/tissue graft combination through the bone tunnel could be used.
- the present disclosure relates to graft fixation members and methods of use in a multiple-bundle technique
- the graft fixation members and methods can be used in a single bone tunnel technique, advantageously with the bone tunnel positioned as tunnel 200 b as shown in FIG. 1 .
- tissue graft fixation procedure may be applicable to other parts of the knee or other parts of the human body requiring tissue reconstruction. Accordingly, other embodiments are within the scope of the following claims. What is claimed is:
Abstract
Description
- This application claims the benefit of U.S. Provisional Application No. 60/783,403, filed Mar. 20, 2006, the disclosure of which is incorporated herein by reference in its entirety.
- This present disclosure relates to tissue graft fixation.
- A ligament, such as an anterior cruciate ligament (ACL), that has ruptured and is non-repairable, is generally replaced arthroscopically by a tissue graft. The tissue graft can be harvested from a portion of a patellar tendon having so called “bone blocks” at each end, and from the semitendonosis and gracilis. Alternatively, the tissue graft can be formed from synthetic materials or from a combination of synthetic and natural materials.
- The replacement tissue graft is implanted by securing one end of the tissue graft in a socket formed in a passage within the femur, and passing the other end of the graft through a passage formed in the tibia. Generally, sutures are used to affix each end of the tissue graft to a fastener (e.g., an interference screw or a post), which is then secured to the bone.
- It is also known to use a graft fixation member, e.g., a fixation button, to secure the tissue graft at the femoral cortex, as described in U.S. Pat. No. 5,306,301 (“the '301 patent”) hereby incorportated by reference in its entirety. The graft fixation member is coupled to the tissue graft and a suture, or other pulling means, is used to pull the fixation member/tissue graft combination through the bone tunnel. However, these fixation members can be cumbersome to use, due to the hole and suture loop placements on the member making it difficult to pass the graft through the tunnel. In addition, the member comes in various sizes, which makes it difficult to center the member on the top opening of the femoral tunnel. Furthermore, as the member is being drawn through the bone tunnel, the member frequently rotates off-axis, rather than maintaining a generally longitudinal orientation.
- According to one aspect, a graft fixation device includes a body configured and arranged for passage through a bone tunnel when oriented generally longitudinally with respect to the bone tunnel, and for residing against bone defining an opening to the bone tunnel when oriented generally transversely with respect to the bone tunnel. The body defines an enclosed channel configured for receiving a tissue graft such that the tissue graft is substantially evenly distributed about a longitudinal extent of the body so that the body maintains a generally longitudinal orientation during passage through the tunnel, and includes a cross bar about which the tissue graft is looped when the body resides against the bone defining the opening to the bone tunnel.
- In an embodiment, the body includes a leading end portion defining a hole, and a trailing end portion defining a hole. In another embodiment, the trailing end portion has an open end or a closed end. In a further embodiment, the trailing end portion has a closed end wherein the closed end is angled relative to the body at an angle α, which is about 45 degrees. In yet a further embodiment, the body includes a trailing end portion having an open end and a leading end portion having an open end.
- In another aspect, a graft fixation device includes an intermediate portion having at least two tabs, the tabs extending transverse to the intermediate portion, the intermediate portion including at least one hole, the hole being located between the tabs.
- In an embodiment,, the device further includes a first end portion including at least one hole and a second end portion including at least one hole. In another embodiment, intermediate portion includes at least two holes. In yet another embodiment, the graft fixation device further includes a continuous loop of material passing through the hole of the intermediate portion. The material may include a suture.
- In yet another aspect, a graft fixation device includes an intermediate portion including a hinge coupled to the intermediate portion, the hinge and the intermediate portion defining a channel configured for receiving a tissue graft.
- In an embodiment, the device further includes a first end portion having at least one hole and a second end portion having at least one hole. In another embodiment, the hinge is U-shaped. In yet another embodiment, the hinge is rotatable relative to the fixation device.
- In another general aspect, a method includes looping a graft through an opening in a graft fixation device, and pulling the graft fixation device and looped graft through a bone tunnel. The graft fixation device is maintained substantially longitudinally oriented relative to the tunnel while being pulled through the bone tunnel.
- Embodiments of this aspect may include drilling at least one bone tunnel extending in a generally lateral direction through a knee joint. In yet another embodiment, the method further includes looping grafts through openings in multiple graft fixation devices, drilling multiple bone tunnels extending in a generally lateral direction through a knee joint, and pulling each of the graft fixation devices and looped grafts through the bone tunnels. The graft fixation devices are each configured such that the graft fixation devices are maintained substantially longitudinally oriented relative to the tunnels while being pulled through the tunnels.
- In a further aspect, a method includes providing a graft fixation device having an intermediate portion including at least two tabs, the tabs extending transverse to the intermediate portion, the intermediate portion including at least one hole, the hole being located between the tabs and including a continuous loop of material, drilling a bone tunnel extending in a generally lateral direction through a knee joint, looping a tissue graft through the continuous loop of material such that the tissue graft is situated between the tabs, and pulling the graft fixation device and looped graft through the bone tunnel, the graft fixation device being configured such that the graft fixation device is maintained substantially longitudinally oriented relative to the tunnel while being pulled through the bone tunnel. The material may include a suture.
- In an embodiment, the method further includes placing the fixation member over an opening to the bone tunnel such that the tabs extend into the bone tunnel. In another embodiment, the graft fixation device further includes a first end portion including at least one hole and a second end portion including at least one hole.
- In yet another embodiment, method further includes providing multiple graft fixation devices, each graft fixation device having an intermediate portion including at least two tabs, the tabs extending transverse to the intermediate portion, the intermediate portion including at least one hole, the hole being located between the tabs and including a continuous loop of material, drilling multiple bone tunnels extending in a generally lateral direction through a knee joint, looping a tissue graft through each of the continuous loop of material such that the tissue graft is situated between the tabs of each of the graft fixation devices, and pulling the graft fixation devices and looped grafts through the bone tunnels, the graft fixation devices being configured such that the graft fixation devices are maintained substantially longitudinally oriented relative to the tunnels while being pulled through the tunnels. Each of the graft fixation devices may further include a first end portion having at least one hole and a second end portion having at least one hole.
- In yet a further aspect, a method includes providing a graft fixation device having an intermediate portion having a rotatable hinge coupled to the intermediate portion, the hinge and the intermediate portion defining a channel configured for receiving a tissue graft; drilling a bone tunnel extending in a generally lateral direction through a knee joint; looping a tissue graft through the channel; and pulling the graft fixation device and looped graft through the bone tunnel, the graft fixation device being configured such that the graft fixation device is maintained substantially longitudinally oriented relative to the tunnel while being pulled through the bone tunnel.
- In an embodiment, the method further includes rotating the hinge relative to the fixation member and placing the fixation member over an opening to the bone tunnel such that the hinge extends into the bone tunnel. In another embodiment, the graft fixation device further includes a first end portion including at least one hole and a second end portion including at least one hole.
- In yet another embodiment, the method further includes providing multiple graft fixation devices, each graft fixation device including an intermediate portion having a rotatable hinge coupled to the intermediate portion, the hinge and the intermediate portion defining a channel for receiving a tissue graft; drilling multiple bone tunnels extending in a generally lateral direction through a knee joint; looping a tissue graft through each of the channels of the multiple graft fixation devices; and pulling each of the graft fixation devices and looped grafts through the multiple bone tunnels, the graft fixation devices being configured such that each graft fixation device is maintained substantially longitudinally oriented relative to the tunnels while being pulled through the tunnels. Each of the graft fixation devices may further include a first end portion including at least one hole and a second portion including at least one hole.
- In another aspect, a graft fixation device includes an intermediate portion having a prominence on a surface of the intermediate portion. The prominence facilitates alignment of a tissue graft with the device as the device is being pulled through a bone tunnel.
- Advantages may include one or more of the following features. Because the tissue graft or suture attached to the fixation member is preferably evenly distributed about the longitudinal extent of the fixation member, the fixation member is advantageously centered within the bone tunnel during passage through the bone tunnel, thus limiting any tendency of the fixation member to snag on the bone tunnel wall. The cross-bar, tabs, and hinge all facilitate centering of the graft or suture relative to the opening to the bone tunnel, thus limiting any tendency of the tissue graft or suture to kink against the bone cortex.
- The details of one or more embodiments of the present disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the present disclosure will be apparent from the description and drawings, and from the claims.
-
FIG. 1 shows a tissue graft secured within tibia and femoral bone tunnels during an ACL reconstruction procedure. -
FIG. 2A is a side view of a fixation member shown drawing the tissue graft through the femoral bone tunnel. -
FIG. 2B is a perspective view of the fixation member ofFIG. 2A . -
FIG. 3A is a side view of an alternative embodiment of a fixation member shown drawing the tissue graft through the femoral bone tunnel. -
FIG. 3B is a perspective view of the fixation member ofFIG. 3A . -
FIG. 4A is a side view of an alternative embodiment of a fixation member shown drawing the tissue graft through the femoral bone tunnel. -
FIG. 4B is a perspective view of the fixation member ofFIG. 4A . -
FIG. 5A is a side view of an alternative embodiment of a fixation member shown drawing the tissue graft through the femoral bone tunnel. -
FIG. 5B is a perspective view of the fixation member ofFIG. 5A . -
FIG. 5C is a bottom view of the fixation member ofFIG. 5A . -
FIG. 5D is an end view of the fixation member ofFIG. 5A -
FIG. 6A is a plan view of an alternative embodiment of a fixation member. -
FIG. 6B is a side view of an alternative embodiment of a fixation member shown drawing the fixation graft through the femoral tunnel. - Referring to
FIG. 1 , during a multiple-bundle, ligament repair and reconstruction procedure,tissue grafts 200 a, 200 b are secured atopenings femoral channels 14 a, 14 b within a knee 100 usinggraft fixation members tissue grafts 200 a, 200 b are tensioned at opposing ends of thechannels 14 a, 14 b from thefixation member tibial channels - The use of a multiple-bundle technique, e.g., more than one
femoral channel 14, tibial channel 16,tissue graft 200 andfixation member 300, results in a repaired joint that is more anatomically correct than a single bundle technique, e.g., a singlefemoral channel 14,tissue graft 200 andfixation member 300. The multiple-bundle technique results in multiple anchor points to transfer stresses evenly across the knee joint and/or permits a surgeon to drill femoral and tibial channels that are more laterally oriented, closer to the joint between thetibia 13 andfibia 15, and shallower than bone channels that are typically drilled farther away from the knee joint, and thus deeper. Further, securing thetissue grafts 200 a, 200 b directly to thefixation members - As shown in
FIG. 2A , thetissue graft 200 is looped through anopening 350 in thefixation member 300 and is pulled through a tibia channel 16 and thefemoral channel 14 using asuture 210 passed through ahole 340 defined in aleading end 300 a of thegraft fixation member 300. - During passage through the
channels 14 and 16, thefixation member 300 is oriented longitudinally within the channels. To limit any tendency of thefixation member 300 to become oriented off-axis of thechannels 14, 16, thetissue graft 200 is looped through the fixation member such that thetissue graft 200 is evenly distributed on either side of thefixation member 300 as the fixation member is pulled through the channels. - Referring to
FIG. 2B , thefixation member 300 is an elongated member having a transversely extendingcross bar 310, a longitudinally extending trailingend portion 320, and a longitudinally extending leadingend portion 330. The trailingend portion 320 includes a pair ofrectangular arms cross bar 310 and defining an open-ended,tissue graft channel 355 therebetween. Thearms holes suture 212, which is used to flip thefixation member 300 after passage through thefemoral tunnel 14 such that thefixation member 300 is positioned against the femur and centered about the femoral opening, as described further below. - The
leading end portion 330 includes a pair ofrectangular arms 330 a, 330 b joined by acurved portion 345 which collectively define an oval-shaped, closed-end,tissue graft opening 350. Thetissue graft 200 is looped through graft opening 350 with the closed-end of the leading end portion ensuring that thegraft 200 remains connected to thefixation member 300. Thecurved portion 345 defines thesuture hole 340. Rather than having a closed end theleading end portion 330 may also be open, similar to the trailingend portion 320. In this embodiment, the fixation member would be in the shape of an “H” and each end would include a pair of rectangular arms having opposing holes for receiving one or more strands of suture. - The
cross bar 310 acts as a fulerum for thetissue graft 200 within the bone channels after passage of the fixation member through the channels and positioning of the fixation member against the femoral cortex, as well as allowing tension to be placed on thetissue graft 200 during subsequent fixation of the tissue graft to the surface of the tibia. - One or more of the
cross bar 310,arms suture openings cross bar 310 relative to the remainder of the fixation member, thegraft 200 that is wrapped around thecross bar 310 can lie relatively flat as the trailing end of thegraft 200 leads away from the fixation member, e.g., thereby ensuring a relatively smooth profile of the combinedgraft 200 andfixation member 300 within thebone channel 14. - An
exemplary fixation member 300 has an overall length of between about 15 mm to about 25 mm, a width of between about 4 mm to about 9 mm, a height of between about 1 mm to about 3 mm, a width of thecentral bar 310 of between about 1 mm to about 2.5 mm, a length of theleading end channel 350 of between about 5 mm to about 12 mm, a width of theleading end channel 350 of between about 3 mm to about 6 mm, and a thickness of therectangular arm portions 330 b of between about 1 mm to about 2 mm. - Other embodiments are within the scope of the following claims.
- For example, referring to
FIGS. 3A and 3B , analternative fixation member 400 includes across bar 410 and aleading end 400 a defining anopening 440 for passage of alead suture 250. Rather than including a closed-end channel and an open-ended, tissue graft channel,fixation member 400 includes a pair of closed-end channels tissue graft 240 is coupled to thefixation member 400 by passing afirst section 240 a of thetissue graft 240 through the first closed-end channel 450 of thefixation member 400 to form agraft loop 240 c which includes the firsttissue graft section 240 a and a secondtissue graft section 240 b. Thefirst section 240 a of the tissue graft is then passed around thecross bar 410 and back through thesecond channel 455. Similarly, thelead suture 250 may be looped through thechannel 450, rather than being passed through theopening 440. - The
fixation member 400 includes a first pair of opposing trailingarms arms arms cross bar 410 and are connected by acurved portion 446. Thecurved portion 446,cross bar 410 andarms end channel 455. Thesecond arms cross bar 410 in a direction opposite from thefirst arms curved portion 445. Thesecond arms cross bar 410 and thecurved portion 445 define the first, closed-end channel 450 at theleading end 400 a of thefixation member 400. The closed-end channels channel 455. - Referring to
FIGS. 4A and 4B , analternative fixation member 500 similar tofixation member 400 is coupled with atissue graft 270 having first andsecond sections tissue graft loop 270 c. Thefixation member 500 includes aleading end portion 500 a and a trailingend portion 500 b, each defining arespective suture hole end portion 500 b including anangled portion 505 for accommodating trailing sections of thetissue graft 270. Theangled portion 505 facilitates centering of thefixation member 500 within the channels during passage through the channels by allowing the tissue graft to be evenly distributed about the longitudinal axis of the fixation member. - This
fixation member 500 defines first and second, generally oval-shaped, closed-end channels fixation member 500 includesfirst arms curved portion 545. The first arms are connected by acurved portion 546. Thefirst arms cross bar 510, andcurved portion 546 define thechannel 555. To formangled portion 505, each of thearms fixation member 500, such that thecurved portion 546 extends along a plane parallel to but offset to the remainder of the device. This offset provides space for thegraft section 270 b as it trails from the fixation member such that the graft is evenly distributed on either side of the fixation member allowing the fixation member to remain centered within the tunnel as it is drawn through the tunnel. - Referring to
FIGS. 5A-5D , analternative fixation member 600 is indirectly coupled to atissue graft loop 290 by acontinuous loop 281 of material passed through central suture holes 682, 683 within anintermediate portion 610 of thefixation member 600. Alead suture 280 is passed through alead suture hole 680 at afirst end portion 605 of themember 600, and a trailingsuture 282 at asecond end portion 620 is passed through a trailingsuture hole 681. Theintermediate portion 610 includes aprominence 630 on asurface 640 of theintermediate portion 610. Theprominence 630 is in the form of a pair of transversely extendingtabs tabs graft 290 with thefixation member 600 thus limiting any tendency of thefixation member 600 to rotate off-axis as it is being drawn through the bone tunnel. In addition,tabs fixation member 600 is positioned against the cortex at the opening to the tunnel, thereby centering themember 600 on the bone. Thematerial 281 may include suture material. - Referring to
FIGS. 6A and 6B , analternative fixation member 700 includes a U-shaped,rotatable hinge 716 coupled to and extending from anintermediate portion 710 of thefixation member 700. TheU-shaped hinge 716 is a rigid, e.g., such as metallic, member which provides a movable mounting surface for directly connecting atissue graft 294 thereto. Theintermediate portion 710 and hinge 716 define achannel 730 therebetween through which the tissue graft is looped. Alead suture 292 is passed through alead suture hole 725 at a leading, or first end 700 a of thefixation member 700, and anothersuture 293 is passed through a trailingsuture hole 720 at a trailing, orsecond end 700 b, for flipping thefixation member 700 to position thefixation member 700 transversely to the bone channel opening. TheU-shaped hinge 716 includes a pair ofarms recesses 718 and/or pivotable about a common pin. When passed through abone tunnel 14, thetissue graft 294 is evenly distributed on either side of thefixation member 700 to limit any tendency of the fixation member to pivot off-axis. When thefixation member 700 is flipped after passage through thebone tunnel 14, theU-shaped hinge 716 rotates relative to the remainder of thefixation member 700 such that thehinge 716 extends into thebone tunnel 14 while the remainder of thefixation member 700 lies against the bone surface, helping to center thefixation member 700 about the bone tunnel opening and center thetissue graft 294 within thebone tunnel 14. - Rather than coupling the tissue graft directly to the fixation member, suture attached to the tissue graft can be coupled to the fixation member. The suture can be coupled to the fixation member in the same manner as the coupling of the tissue graft directly to the fixation member, as described above.
- The channels can be a variety of shapes, including circular, oval, elliptical and/or rectangular. The arms can also have a variety of shapes.
- The leading and/or trailing ends can each be provided with one or more suture holes to facilitate positioning of the fixation member within the bone tunnel, and drawing the fixation member through the bone tunnel, and flipping the fixation member. A strand of suture can be extended between the opposing holes (
FIG. 2 b, 321 a, 321 b) to serve as a stop to enclose the otherwise open end of thechannel 355 to secure the trailing end of the tissue graft bundle to the trailing end of the fixation member. The graft fixation member is formed from a biocompatible material such as titanium or PEEK, or a bioabsorbable material. The tissue graft may include autograft tissue, allograft tissue, or synthetic tissue. Additionally, instead of being positioned against the outer surface of the cortex at the opening to the femoral tunnel, the fixation member may be positioned inside the bone, thereby lying against the endosteal surface of the near cortex. As described above, suture material is used. However, other material known to one of ordinary skill in the art that is strong enough to withstand pulling the fixation member/tissue graft combination through the bone tunnel could be used. - Although the present disclosure relates to graft fixation members and methods of use in a multiple-bundle technique, the graft fixation members and methods can be used in a single bone tunnel technique, advantageously with the bone tunnel positioned as
tunnel 200 b as shown inFIG. 1 . - The aforementioned tissue graft fixation procedure may be applicable to other parts of the knee or other parts of the human body requiring tissue reconstruction. Accordingly, other embodiments are within the scope of the following claims. What is claimed is:
Claims (34)
Priority Applications (2)
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US11/688,447 US9314236B2 (en) | 2006-03-20 | 2007-03-20 | Tissue graft fixation |
US15/065,265 US20160184083A1 (en) | 2006-03-20 | 2016-03-09 | Tissue graft fixation |
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US78340306P | 2006-03-20 | 2006-03-20 | |
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JP (1) | JP5166395B2 (en) |
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WO (1) | WO2007109665A1 (en) |
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Also Published As
Publication number | Publication date |
---|---|
EP2007316B8 (en) | 2012-07-11 |
US20160184083A1 (en) | 2016-06-30 |
JP5166395B2 (en) | 2013-03-21 |
JP2009530061A (en) | 2009-08-27 |
EP2007316B1 (en) | 2012-04-25 |
US9314236B2 (en) | 2016-04-19 |
ATE554729T1 (en) | 2012-05-15 |
AU2007226948B2 (en) | 2012-12-06 |
EP2007316A1 (en) | 2008-12-31 |
WO2007109665A8 (en) | 2009-03-26 |
WO2007109665A1 (en) | 2007-09-27 |
AU2007226948A1 (en) | 2007-09-27 |
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